FDA 510(k) Application Details - K213844

Device Classification Name	Gown, Surgical   More FDA Info for this Device
510(K) Number	K213844
Device Name	Gown, Surgical
Applicant	Bayteks Teknik Tekstil San. ve Tic. A.S. Organize Sanaji Bolgesi 19. Nolu Cad. No. 9 Merkez 79000 TR Other 510(k) Applications for this Company
Contact	Spero Hegbe Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2021
Decision Date	02/16/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review